FRESH N UP (BENZALKONIUM CHLORIDE) SOLUTION [ROCKLINE INDUSTRIES, INC]

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FRESH N UP (BENZALKONIUM CHLORIDE) SOLUTION [ROCKLINE INDUSTRIES, INC]
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NDC 57624-601-15
Set ID f886b704-0a6a-4bc3-8bfd-d97996eb25d0
Category HUMAN OTC DRUG LABEL
Packager Rockline Industries, Inc
Generic Name
Product Class
Product Number
Application Number PART333A
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  • Active Ingredient

    Benzalkonium chloride 0.115%

  • Purpose

    Antibacterial

  • Uses

    For hand washing to decrease bacteria on the skin
  • Warnings

    For external use only

  • When using this product

    avoid the eyes and mucous membranes
    If contact occurs, rinse eyes thoroughly with water
  • Stop use and ask a doctor if

    if irritation develops and persists for more than 72 hours.
  • Keep out of reach of children

    Keep out of reach of children. If swallowed contact a doctor or Poison Control Center right away.

  • Other Information

    May be used on face, arms and legs.
  • Directions

    • For use apply thoroughly to hands and face as desired. Allow to dry without wiping. Discard wipe in trash receptacle after use. Do not flush.
    • For dispensing tear open package at notch. Dispose of wrapper in trash. Do  not flush
  • Inactive Ingredients

    Acrylates Copolymer, Benzophenone-4, Citric Acid, Cocamide DEA, Cocamidopropyl Betaine, Disodium EDTA, FDC Yellow 5, FDC Blue 1, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Sodium Chloride, Sodium Laureth Sulfate, Water
  • Package Label

    Package label
    image of package label



  • INGREDIENTS AND APPEARANCE
    FRESH N UP 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57624-601
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.115 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57624-601-150.115 mL in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/01/2010
    Labeler - Rockline Industries, Inc (066886102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hgiene Salud, S.A. de C.V.814608832manufacture
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